Biomarker Development & Validation

Biomarker development supports the measurement of biological processes, pharmacologic responses, or disease progression during development. Biomarkers are often used to inform dose selection, patient stratification, and assessment of treatment response.

Effective biomarker strategies require early planning to ensure biological relevance, analytical feasibility, and alignment with clinical endpoints. Validation considerations are critical to support regulatory acceptance and data interpretation.

Well-designed biomarker programs enhance translational insight and clinical decision-making.

Biomarker development activities often include:

• Biomarker strategy and selection

• Assay feasibility and validation planning

• Integration with clinical study design

• Data interpretation and analysis

• Alignment with regulatory expectations